EUSFDA 和GMP对比不同.pptVIP

EU GMP Seminar of EU-GMP guideline practice 欧洲GMP 方针实践 EU-China GMP Comparison 欧洲-中国 GMP 的比较 Summary 概要 Why we need to pay attention to EU GMP? 为何要关注欧洲GMP？ Attention to on-site manufacturer 对于定点加工商的关注 Why we need to pay attention to EU GMP regulation? 为何要关注欧洲GMP法规？ For operating European regulation better —— regulations comparison 为了更好的执行欧洲法规——法规对比 European is concerning about us欧洲正在关注我们 European – or German - companies in the pharmaceutical field are targeted at procuring active pharmaceutical ingredients or even finished pharmaceuticals from China – or at their partial manufacture in China. 欧洲公司已经开始将目标放在从中国工厂或者他们在中国的合资生产单位处获得活性药物成分（即API)甚至制剂成品。 In these circumstances, regulations stipulate that the on-site capacity of the contractual partner should be checked and, in almost all cases, an audit carried out for this purpose.在此情况下，法规规定几乎所有定点合约加工商都要接受GMP检查。 The work executed at the Chinese company has to be performed according to the European GMP Guideline. To understand and to assess the differences between the European GMP requirements and those from the SFDA GMP, it is beneficial to have knowledge about the content, the implementation and the understanding of both, the guidelines of Europe and those of China.中国企业必须按照欧洲GMP的准备进行生产工作。为了理解和评估欧洲GMP和中国GMP要求之间的区别，拥有欧洲和中国的GMP法规的内容、执行方式的相关知识，以及对两者具有一定理解是非常有益的。 The Chinese GMP Guideline establishes a good basis for guaranteeing quality and safety in the manufacture and control of pharmaceuticals. For a comprehensive implementation of the regulatory requirements of theEU-GMP Guide, Chinese producers need to add the missing requirements to the Chinese Guideline.中国GMP方针为保证生产及控制药品的质量与安全建立了良好的基础。为了更全面的执行欧洲GMP法规，中国制造商应该将中国GMP方针中缺失的部分加入其中。 Disadvantages of Chinese GMP for European中国GMP对于欧洲的弊端 Chinese GMP system is based on independent and not international rules, which are furthermore not published in English by the SFDA 中国GMP系统是建立在独立的非国际性的条例系统上的，此外，SFDA也没有出版英文版本。 Chinese pharmaceutical